GI Dynamics, a medical device company that is developing EndoBarrier for patients with type 2 diabetes and obesity, has received Institutional Review Board (IRB) approval to conduct its pivotal trial of EndoBarrier for type 2 diabetes and obesity.
As announced on 13 August 2018, the pivotal trial of EndoBarrier, referred to as the
18-1 study, is a randomized (3:1) controlled double-blinded clinical trial designed to measure the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication for the treatment of type 2 diabetes and obesity vs. a sham control arm in conjunction with lifestyle therapy and diabetes medication, also for the treatment of type 2 diabetes and obesity.
The 18-1 study will occur in two stages. Stage I consists of 50 EndoBarrier patients and approximately 17 control patients and will be completed with the filing of four Data Monitoring Committee (DMC) reports with the US Food and Drug Administration (FDA). Upon review of the four DMC reports by the FDA, the company will apply for approval to conduct Stage II of the trial, which is projected to include the balance of patients to complete the 18-1 study total of 240 patients (180 EndoBarrier and 60 control).
IRB approval is required by the FDA and is an essential step to allow the EndoBarrier pivotal trial to proceed. Western IRB (WIRB) is serving as the company’s central IRB. GI Dynamics was notified today that the following EndoBarrier pivotal trial documentation is approved by WIRB: protocol, informed consent form, and investigator’s brochure.
“When we announced that the FDA approved our Investigational Device Exemption (IDE) for the pivotal trial of EndoBarrier, the approval was conditional upon IRB approval,” said Scott Schorer, president and chief executive officer of GI Dynamics. “This IRB approval now satisfies that condition. In parallel, we continue to push forward with the clinical study sites that will be part of the 18-1 study and we anticipate being in a position to announce these clinical sites shortly.”
Source: Company Press Release